Surgical Tissue Flap for Glioblastoma
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Surgical Tissue Flap for Glioblastoma?
Research shows that surgical resection, which involves removing as much of the tumor as possible, is a key part of treating glioblastoma and can improve survival. Techniques like using imaging and neuronavigation help make the surgery more precise and safer, which might relate to the effectiveness of using a surgical tissue flap.12345
Is the surgical tissue flap procedure for glioblastoma generally safe?
The safety of surgical procedures for glioblastoma, including the use of surgical tissue flaps, can be affected by risks such as surgical site infections and the need for platelet transfusions. Infections occurred in about 7.9% of patients, and platelet transfusions were needed in 12.38% of cases, often due to factors like prior antiplatelet therapy and low preoperative platelet counts.678910
How does the Surgical Tissue Flap treatment for glioblastoma differ from other treatments?
The Surgical Tissue Flap treatment for glioblastoma is unique because it involves using a piece of tissue to cover or repair areas affected by surgery, which may help in healing and protecting the brain after tumor removal. This approach is different from other treatments that focus solely on removing the tumor or using drugs to target cancer cells.211121314
What is the purpose of this trial?
This study assesses the safety of using tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.The objective of the study is to demonstrate that this surgical technique is safe in a small human cohort of patients with resected newly diagnosed GBM and may improve progression-free survival (PFS).
Research Team
John Boockvar, MD
Principal Investigator
Northwell Health
Eligibility Criteria
This trial is for adults over 18 with newly diagnosed GBM who are expected to live at least 6 months and can have an MRI. They must be able to undergo a specific surgery, use birth control if of reproductive potential, sign consent, have a KPS of 70% or more, and meet certain lab criteria. Pregnant women, those already treated for GBM or with active infections or other significant health risks are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Treatment
Standard surgical resection followed by implantation of a TPF or pericranial flap into the resection cavity
Follow-up
Participants are monitored for safety and effectiveness after the surgical treatment, including MRI assessments and monitoring for progression-free survival
Long-term Follow-up
Participants are monitored for overall survival and long-term safety outcomes
Treatment Details
Interventions
- Surgical Tissue Flap
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor